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ISO/TR 15499:2016

Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process

General information

Withdrawn from 22.10.2018
Directives or regulations
None

Standard history

Status
Date
Type
Name
13.12.2016
Main
Main
ISO/TR 15499:2012
ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

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